Prehospital Tranexamic Acid Use for Traumatic Brain Injury
Abstract
The primary aim is to determine the efficacy (comparing 6 month GOSE) of two dosing regimens of TXA initiated in the pre-hospital setting in patients with moderate to severe TBI (GCS score 3-12).The first year has been spent in preparation for study implementation including approvals by the ROC Protocol Review Committee and Data, Safety Monitoring Board, as well as obtaining an FDA IND and Health Canada CTA. The documents for the first site approval were sent to HRPO on June 19, 2014 and final approval by the Sec. Army occurred on 2/8/2015. A web data entry system to collect the patient data and check for errors (and a detailed Manual of Operations) was completed. Enrollment started on 5/18/2015. Nine of 12 sites have started enrollment. One Canadian site had to suspend enrollment due to issues of patient privacy. It is expected that all sites will be enrolling by January of 2016. Enrollment is projected to be completed by November of 2016 with the last GOSE evaluation in early 2017.
Document Details
- Document Type
- Technical Report
- Publication Date
- Oct 01, 2015
- Accession Number
- AD1002681
Entities
People
- Judy Powell
- Marty Schreiber
- Susan Rowell
- Susanne May
Organizations
- University of Washington